{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2019-10305", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20190425", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "CONSUMER", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190425", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "343358", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190425", "brand_name": "DA VINCI", "generic_name": "DA VINCI SURGICAL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20190425", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection", "Injury", "Unspecified Infection", "Injury" ] } ], "distributor_city": "", "date_report": "20190410", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8551911", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190410", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "143230636", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE ALLEGED OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT CANNOT BE DETERMINED. THE FOLLOWING INFORMATION IS UNKNOWN: THE SPECIFIC TYPE OF DA VINCI-ASSISTED SURGICAL PROCEDURE PERFORMED, WHAT HOSPITAL THE SURGICAL PROCEDURE WAS PERFORMED, THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE, AND THE SURGERY DATE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT CLAIMED THAT SHE EXPERIENCED POST-OPERATIVE COMPLICATIONS AND A HOLE IN HER COLON WAS FOUND. HOWEVER, AT THIS TIME, THE ROOT CAUSE(S) OF THE ALLEGED OPERATIVE COMPLICATIONS ARE UNKNOWN." }, { "mdr_text_key": "143230637", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON APRIL 10, 2019, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE FOLLOWING SOCIAL MEDIA POSTING: \"I DONE FILED A COMPLAINT ON THE COLON SURGEON WHO USED THIS MACHINE ON MY COLON LAST JULY. I ENDED OFF AFTER A MONTH OF HAVING BLOATING AND GAS THIS LEAD TO A HOLE IN MY COLON AND NOW I GOT COLITIS CAUSE IF YOUR MESSED UP JUNK MACHINE. AND I AM SUING NO DOUBT ABOUT IT I COULD HAVE DIED 2 MONTHS AGO.\" ON 04/12/2019, ISI CONTACTED THE PATIENT AND THE FOLLOWING INFORMATION REGARDING THE ALLEGED EVENT WAS OBTAINED: THE PATIENT UNDERWENT COLON SURGERY ON AN UNSPECIFIED DATE IN 2018. A MONTH AFTER SURGERY, THE PATIENT STARTED HAVING \"TUMMY PAINS AND A LOT OF PAIN.\" THE PATIENT ENDED UP HAVING DIAGNOSTIC LAPAROSCOPIC SURGERY ON (B)(6) 2019 AND A HOLE IN HER COLON WAS FOUND. SHE NOW HAS COLITIS. THE PATIENT BELIEVES THE DA VINCI SURGICAL SYSTEM CAUSED HER OPERATIVE COMPLICATIONS. THE PATIENT HAD HER SURGERIES PERFORMED IN (B)(6)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }